University of Cologne, Cologne, Germany.
Appl Health Econ Health Policy. 2009;7(3):181-91. doi: 10.1007/BF03256151.
Sinfrontal, a complex homeopathic medication, is popular in Germany for the treatment of ear, nose and throat and respiratory tract infections. Unlike many other homeopathic or herbal medications, the efficacy and safety of Sinfrontal has been demonstrated in a number of clinical studies of patients with sinusitis. To assess the cost effectiveness of Sinfrontal versus placebo in the treatment of adults with acute maxillary sinusitis (AMS) in Germany. A secondary objective was to assess the cost effectiveness of Sinfrontal versus standard treatment with antibacterials. Sinfrontal was compared with placebo in a cost-utility analysis based on data from a randomized controlled clinical trial over 3 weeks (Sinfrontal group: n = 57; placebo group: n = 56). Trial data were analysed from a societal perspective; resource use was valued with German unit costs for 2005. In a secondary analysis, the longer-term cost utility of Sinfrontal versus placebo was estimated over a total of 11 weeks based on an 8-week post-treatment observational phase. In addition, the cost effectiveness of Sinfrontal versus antibacterials was determined based on an indirect comparison of placebo-controlled trials. Sinfrontal led to incremental savings of euro 275 (95% CI 433, 103) per patient compared with placebo over 22 days, essentially due to the markedly reduced absenteeism from work (7.83 vs 12.9 workdays). Incremental utility amounted to 0.0087 QALYs (95% CI 0.0052, 0.0123), or 3.2 quality-adjusted life-days (QALDs). Bootstrapping showed that these findings were significant, with Sinfrontal being dominant in 99.9% of simulations. The results were robust to a number of sensitivity analyses. In the secondary analysis, Sinfrontal led to incremental cost savings of euro 511 and utility gains of 0.015 QALYs or 5.4 QALDs compared with placebo. Compared with antibacterials, Sinfrontal had a significantly higher cure rate (11% vs 59%; p < 0.001) at similar or lower costs. The results of this economic evaluation indicate that Sinfrontal may be a cost-effective treatment for AMS in adults.
辛福隆,一种复方顺势疗法药物,在德国常用于治疗耳、鼻、喉和呼吸道感染。与许多其他顺势疗法或草药药物不同,辛福隆已在多项鼻窦炎患者的临床研究中证明了其疗效和安全性。评估辛福隆与安慰剂在治疗德国成人急性上颌窦炎(AMS)中的成本效益。次要目标是评估辛福隆与抗菌药物标准治疗相比的成本效益。在一项为期 3 周的随机对照临床试验(辛福隆组:n = 57;安慰剂组:n = 56)的基础上,对辛福隆与安慰剂进行成本效用分析。基于 2005 年德国单位成本,从社会角度分析试验数据;资源使用情况。在二次分析中,根据 8 周治疗后观察期,总共 11 周,估计辛福隆与安慰剂的长期成本效益。此外,根据安慰剂对照试验的间接比较,确定了辛福隆与抗菌药物的成本效益。与安慰剂相比,辛福隆在 22 天内为每位患者节省了 275 欧元(95%CI 433,103),主要是由于旷工天数明显减少(7.83 与 12.9 个工作日)。增量效用为 0.0087 QALY(95%CI 0.0052,0.0123)或 3.2 个质量调整生命日(QALDs)。自举显示,这些发现具有统计学意义,99.9%的模拟中,辛福隆具有优势。结果在多项敏感性分析中具有稳健性。在二次分析中,与安慰剂相比,辛福隆的成本节省了 511 欧元,效用增加了 0.015 QALY 或 5.4 QALDs。与抗菌药物相比,辛福隆的治愈率明显更高(11%与 59%;p < 0.001),成本相似或更低。这项经济评估的结果表明,辛福隆可能是治疗成人 AMS 的一种具有成本效益的治疗方法。